11 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
Armada
FDA UDI
Nuvasive, Inc.·00887517235237·Armada Ti 3CO Osteotome, 5mm Cervical
Prefix Fixator
FDA UDI
ORTHOFIX SRL·18033509855962·PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG ...
GM501 Wash with Phenol Red and Gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RADAR VASCULAR COMPRESSION DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·March 4, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code JDW·September 27, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024